Tongue retention device

ABSTRACT

A device for retaining a tongue in a predetermined position, the device comprising, a flange having a first and second surface, the flange further including a protrusion extending from the first surface of the flange; and an aperture formed through the first and second surfaces of the flange, wherein the protrusion covers the aperture, whereby the protrusion form a hollow chamber, the hollow chamber is accessible through the aperture from the second side of the flange.

1. FIELD OF THE INVENTION

[0001] The present invention relates to dental devices for treatingsnoring and sleep apnea, more particularly the present invention relatesto devices for positioning and restraining the tongue of a person.

2. RELATED ART

[0002] Many studies have been undertaken to better understand snoringand sleep apnea. It has been well documented that snoring occurs whilebreathing through the mouth during sleep when the tongue partiallyblocks the airway. Thus, one way to cure or mitigate snoring is to holdthe tongue in a forward position, whereby airway blockage cannot occur.Although generally merely an annoyance to those other than the personsnoring, it is known that in certain instances airway blockage willbecome complete resulting in apnea, i.e., a cutting off of the airsupply to the lungs and thus decreasing the amount of oxygen carried bythe blood to the brain.

[0003] Sleep apnea not only interrupts a persons sleep patternsresulting in chronic fatigue, it can also cumulatively cause braindamage. Therefore, for many persons, reducing or eliminating snoring isa serious matter. Sleep apnea can be classified into three basiccategories, 1.) Central apnea, 2.) Obstruction Apnea, and 3.) MixedApnea.

[0004] Central apnea is classified as a stoppage of airflow becauseinspiratory efforts temporarily cease. The airway remains open and thechest walls make no effort to create airflow. The potential medicaleffects which may result due to central apnea are: encephalitis,brainstem neoplasm, brain stem infarction, poliomyelitis, spinal cordinjury, and cervical cordoromy.

[0005] Obstruction apnea is classified as the cessation of airflow dueto total airway collapse despite a persistent effort to breath. Anobstruction in the upper airway can occur in three areas which are, a.)Nasopharyngeal, b.) Oropharyngeal, and c.) Hypopharyngeal regions.

[0006] Mixed apnea is classified as a combination of central andobstructive apnea usually beginning with a central episode beingimmediately followed by an obstructive one.

[0007] Many devices have been developed to address the problem of sleepapnea. One such device is Continuous Positive Airway Pressure (CPAP)this technique involves wearing a mask tightly over the nose duringsleep. Pressure from an air compressor forces air through the nasalpassages and into the airway. This forced air creates a pneumaticsplint, keeping the airway open and allowing the person to sleepnormally. Though this technique is highly effective, this therapy is notfor everyone. In fact, daily compliance by persons using CPAP is lessthan 50%. Furthermore, this technique has many drawbacks some of whichare that it is uncomfortable, inconvenient, restricts the person'smotion and dries out the mucosa. Further still, there is also a realconcern of having reduced cardiac output and renal function.

[0008] Another approach to treating apnea is to surgically alter theperson's breathing passages. The most effective surgical procedures fortreating apnea is a tracheostomy which enjoys a 100% success ratebecause it completely bypasses all of the sites of the upper airwayobstruction. Although it is rarely accepted by persons because manycannot accept the idea of permanent tracheostomy. A number ofcomplications emerge with time, some of which are tracheal siteinfection, physiological problems, granulona formation, chronicirritation, uncontrolled secretions, bronchial infections and eventualstenosis.

[0009] A different surgical approach is nasal reconstruction. Many timesa nasal obstruction causes a person to mouth breath, when you breaththrough your mouth the mandible rotates back and allows the base of thetongue to drift posteriorly and block the airway.

[0010] A still further surgical method that may be employed isuvulopalatopharyngoplasty (UPPP). This procedure enlarges the air spaceby excising redundant soft tissue of the palate, uvula, tonsils,posterior and lateral pharyngeal walls. This procedure can be quitesuccessful at stopping snoring, most studies indicate that this methodis approximately 50% effective.

[0011] In addition to the techniques and devices above, there is stillanother series of devices that have been developed to treat sleep apnea.These devices can be classified as dental appliances. Dental appliancesmay be in the form of a soft palate lift device and tongue retentiondevices.

[0012] Many types of tongue holding devices are known. For example,metallic or hard plastic clips are disclosed in the art, e.g., in U.S.Pat. No. 4,198,967—Dror and U.S. Pat. No. 3,809,094—Crook. However,these devices risk pain and injury to the tongue, and are particularlyunsuited to self-administration. A less traumatic device designed forself-administration and for extended periods of use (i.e., overnight) isdisclosed in U.S. Pat. Nos. 4,169,473 and 4,304,277, both to Samelson.The device disclosed in the Samelson patents evacuates air from a tongueholder and uses an imperforate structure in a device that is positionedby holding both dental arches in a locked position. Such a device,however, is detrimental to the normal bite relationship of the dentalarches since it distorts the relationship of the upper and lower jaws.U.S. Pat. No. 4,196,724—Wirt discloses a tongue receptacle having arearwardly converging configuration into which the tip of the tongue iswedged. However, the device disclosed in the Wirt patent causes pain,swelling and edema by concentrating an applied vacuum to a small area ofthe tip of the tongue. Furthermore, the requirement for an attachment toa vacuum-producing device such as the disclosed elastically contractiblebellows is cumbersome and annoying to a sleeping user. U.S. Pat. No.4,676,240—Gardy proposes a device that engages either the teeth or thegum arches to anchor the device in position. The tongue is received in avacuum chamber and displaces the air therein. The tongue is sealed inthe chamber by internal sealing ridges located on the inside of thevacuum chamber.

[0013] Another such tongue retention device is described in U.S. Pat.No. 5,373,859 Forney and shown in FIG. 6. The Forney device, asillustrated in FIG. 6, is designed to retain the tongue in a normal orextended position without undue discomfort for an extended period oftime by holding the tongue securely in a housing by means of vacuumcreated within the device. The housing may then be positioned by holdingit with the fingers or, in another embodiment, by an integral flangewhich rests against the face and permits self-application. The deviceuses a housing that is designed to form a seal with the tongue at itsproximal portion, and diverging walls within the housing to limit otherareas of contact with the tongue. The device also preferably uses anopening that is arcuate shaped and includes a soft conformable extensionportion.

[0014] Shortcomings of these devices are that the device extends beyondthe person's teeth and into the oral cavity. Additionally, the devicecannot be custom fitted to each individuals anatomy because anymodifications to the distal portion of the device will reduce theoverall vacuum effect. Still further, many of these devices areconstructed of thick non-yielding materials that when in use prove to bevery uncomfortable to be worn for extended periods of time because thedevice will not conform to the users anatomy. Another shortcoming ofmany of these devices is that the portion of the device adapted toreceive the person's tongue are not designed having a limited volume,thus the user may insert a greater amount of tissue into the devicetherefore resulting in great discomfort to the user. Lastly, many of thepresently available devices further include stiffening means disposedwithin the device, many times the stiffening means is in the form ofribs disposed within the area adapted for receiving the person's tongue,thus when a vacuum is drawn to retain the device upon the person'stongue these stiffening ribs prove to be uncomfortable.

[0015] There remains a need for a device that can position a person'stongue in an extended manner to treat sleep apnea. It is therefore anobject of this invention to provide a pliable device which comfortablyholds a tongue using vacuum forces.

[0016] It is another object of the present invention to provide a devicewhich may be comfortably worn while sleeping and which does not extendinto the oral cavity of the person.

[0017] It is a further object of the present invention to provide adevice which may be easily cleaned after use.

[0018] It is still a further object of the present invention to providea device for retaining a person's tongue in an extended manner where thedevice does not require great manual dexterity to utilize.

BRIEF DESCRIPTION OF THE INVENTION

[0019] In accordance with one aspect of the present invention there isprovided a device for retaining a tongue in a predetermined position,the device comprising, a flange having a first and second surface, theflange further including a protrusion extending from the first surfaceof said flange. The device further including an aperture formed throughsaid first and second surfaces of said flange, wherein the protrusioncovers the aperture, whereby the protrusion forms a hollow chamber, thehollow chamber being accessible through the aperture from the secondside of the flange.

[0020] In accordance with another aspect of the present invention thereis provided a device for retaining a tongue in a pre-determinedposition, the device comprising, a flange having a first and secondsurface, an aperture disposed within the flange wherein the aperturefurther includes walls extending from the first surface of a flange, thewalls forming a bulb protruding from the first surface of the flange,wherein the bulb forms a chamber in communication with the aperture andbeing adapted to receive a tongue.

[0021] In accordance with another aspect of the present invention thereis provided a method of retaining a tongue in a predetermined position,the method comprising, forming a vacuum within a tongue retention deviceby squeezing the walls of an protrusion extending from a flange of thetongue retention device, inserting a tongue through an aperture formedin the flange, wherein the tongue is received by the protrusion,releasing the walls, thereby forming a vacuum within the protrusion; andpositioning the tongue retention device between a user's lips and teeth.

DETAILED DESCRIPTION OF THE DRAWINGS

[0022] The invention will now be described in greater detail withreference to preferred embodiments illustrated in the accompanyingdrawings, in which like elements bear like numerals; and wherein;

[0023]FIG. 1 is a top view of the tongue retention device of the presentinvention;

[0024]FIG. 2 is a front view of the tongue retention device illustratinga flange and a protrusion that extends from said flange;

[0025]FIG. 3 is a back view of the tongue retention device illustratingthe aperture formed in the flange, wherein the aperture is incommunication with the protrusion;

[0026]FIG. 4 is a side view of the tongue retention device;

[0027]FIG. 5 is a perspective side view illustrating the flange,protrusion, and aperture;

[0028]FIG. 6 is an illustration of a prior art tongue retention device.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0029] Referring now FIG. 1 there is shown a tongue retention device 10of the present invention. The tongue retention device 10 includes aflange 14, an aperture 16 and a bulb 18. The tongue retention device 10is preferably formed as a unitary body wherein a soft pliable materialis utilized in its construction. Such materials which may be utilizedfor the construction of tongue retention device 10 arepolyvinylchloride, polyethylene, urethane, silicon or other similarbio-compatible materials. One such material that may be used toconstruct tongue retention device 10 of the present invention isreferred to as “Sta-Vac sheet resin” which is available from a number ofcommercial manufacturers such as Buffalo Dental Manufacturing Company,99 Lafayette Drive, Syosset, N.Y. 11791 USA.

[0030] The tongue retention device 10 may be formed having a constantthickness across it's entire cross section or alternatively, the crosssectional thickness may be varied according to design needs, preferablythe tongue retention device 10 is formed having a thickness betweenabout 0.010 inches and about 0.060 inches, more preferably between about0.025 inches and about 0.040 inches.

[0031] As shown in FIGS. 1-5 tongue retention device 10 of the presentinvention may be formed by blow molding, injection molding, casting,vacuum forming or similar manufacturing procedures which will result inthe formation of a one piece body.

[0032] Referring now to FIGS. 1,3, and 5 there is shown the tongueretention device 10 of the present invention. As shown, the tongueretention device 10 includes a bulb 18. The bulb 18 is unitarily formedwith flange 14 thereby forming a one piece tongue retention device 10 asdescribed in detail above. As shown in FIGS. 4 and 5 the bulb is formedof walls 19 extending from the first surface 13 of the flange 14 formingthe bulb 18. Additionally, as indicated by reference numeral 20, thebulb 18 forms a smooth transition with the first surface 13 of flange 14thereby eliminating any sharp edges or surfaces which may contact theperson's skin. Still further, the interior surfaces of bulb 18 areformed having a smooth surface finish. This smooth surface finishpromotes easy cleaning in that bacteria cannot become lodged within anycreases or openings in the surface. Additionally, the smooth surfaceprovides a degree of comfort to the user.

[0033] As shown in FIGS. 1-5 the bulb 18 is formed being adapted toreceive a person's tongue. The bulb 18 is also designed having apre-determined volume such that only a pre-determined amount of theperson's tongue will be received by the interior of the bulb 18. Asshown in FIG. 3, the aperture 16 is designed having an elongated shapehaving radiused ends whereby the aperture may receive a person's tongue.The proximal area 17A of the aperture 16 is radiused accordingly so thatthe area 17A provides a smooth transition between the aperture 16 andthe second surface 12. The distal area 17B (not shown) is also radiusedto provide a smooth transition between the aperture 16 and the innersurface of the walls 19 of the bulb 18. In addition to the featuresabove, the thickness of the material utilized to construct the tongueretention device 10 provides a sufficient amount of vacuum force withinbulb 18 to retain the person's tongue therein but not a force that is togreat as to cause pain and discomfort to the person.

[0034] Referring now to FIGS. 1-6 as shown, the flange 14 of the tongueretention device 10 further includes a curved portion 30. The curvedportion 30 may be adjusted to fit the user's jaw line so that during usethe device comfortably fits between the users teeth and lips. Stillfurther, the overall size of the flange 14 may be adjusted by trimmingto accommodate the sizes of different person's mouths. This feature alsoallows for the manufacture of a single size of the tongue retentiondevice 10 thereby lowering overall production costs of the device.Alternatively, the tongue retention device 10 may be manufactured havingmultiple size variations in which both the flange and volume of the bulb18 are adjusted accordingly.

[0035] In use, the bulb 18 of the tongue retention device 10 is grippedby the user and the user then places the tip of their tongue into theaperture 16 and the bulb 18 is squeezed to reduce the air volume withinthe bulb 18. By squeezing the bulb 18, air is forced out of the bulbpast the person's tongue, when the force is released from the bulb 18,due to the resiliency of the material the bulb tries to return to it'suncompressed shape. In doing so, a vacuum is formed within the bulbbecause the tongue inserted into the aperture 16 provides a seal betweenthe interior of the bulb 18 and the external atmospheric pressure. Thus,the tongue retention device 10 is thereby retained on the person'stongue. Alternatively, the person may insert their tongue throughaperture 16 and into the bulb 18, after insertion they may then affixthe tongue retention device by sucking back on the device and drawingair out of the bulb 18 thereby forming a vacuum therein. In utilizingeither method, the user does not have to have a great deal of manualdexterity to affix the device to their tongue.

[0036] After affixing the tongue retention device to their tongue, thedevice is then positioned within the mouth, such that the second surface12 of the flange 14 abuts the person's teeth and the first surface 13 ofthe flange 14 rests just behind the person's lips. Thus, in use, thetongue retention device 10 does not extend into the oral cavity of theperson. Additionally, the tongue is accurately held into apre-determined position. The position can be accurately reproduced witheach use of the device, therefore the user is not required to adjust anyparameter of the device between uses.

[0037] If needed, as described above, the overall size of the flange maybe easily adjusted to accommodate a wide variety of geometries. Forexample, the flange may be trimmed down to fit a smaller mouth, or thecurved portion 30 may be heat formed into a different curvature that maybe more comfortable. In addition to providing treatment for sleep apnea,the tongue retention device of the present invention may also beutilized in applications regarding the treatment of bruxism (thegrinding of teeth while sleeping) and thereby TJM muscle point for boththose with teeth and without teeth.

[0038] Throughout the description above many advantages over the priorart are described. Such advantages include the limited volume of thebulb 18 thereby limits the volume of the tongue that will be retained bythe tongue retention device 10. Still further, the tongue retentiondevice 10 is formed of a material having a desired thickness such thatoverall the device remains pliable and resilient thereby resulting in atongue retention device that is both comfortable and easy to use. Stillfurther the design features of the present invention allow the tongueretention device 10 to be custom fitted for each application, therebypromoting comfort to the person while reducing overall manufacturingcosts, alternatively, the design of the tongue retention device 10allows for manufacture of various sizes. Also, unlike presentlyavailable devices, the tongue retention device 10 of the presentinvention does not protrude into the oral cavity. Lastly, the tongueretention device 10 of the present invention may be utilized in otherapplications such as the treatment of bruxism.

[0039] The foregoing description of certain preferred embodiments is setforth for the purpose of illustrating the principals of the invention.Since numerous alternative uses, modification and changes will readilyoccur to those skilled in the art, it is not desired to limit theinvention to the exact construction and operation shown and describedabove, in the drawings and within the claims. Thus, all suitablemodifications and equivalents that may be reported to will fall withinthe scope of the invention, which is defined by the appended claims.

1. A device for retaining a tongue in a predetermined position, thedevice comprising: a flange having a first and second surface, saidflange further including a protrusion extending from said first surfaceof said flange; and an aperture formed through said first and secondsurfaces of said flange, wherein said protrusion covers said aperture,whereby said protrusion forms a hollow chamber, said hollow chamberbeing accessible through said aperture from said second side of saidflange.
 2. The device according to claim 1, wherein said flange andprotrusion are formed as a unitary body.
 3. The device according toclaim 2, wherein said aperture is adapted to receive a tongue.
 4. Thedevice according to claim 2, wherein said device is constructed of apliable material chosen from the group consisting of polyethylene,urethane, silicon, and polyvinylchloride.
 5. The device according toclaim 2, wherein a vacuum may be formed within said protrusion bycompressing said protrusion and inserting a tongue into said aperture.6. The device according to claim 2, wherein said flange is adapted to bereceived between a person's lips and teeth.
 7. A device for retaining atongue in a pre-determined position, the device comprising: a flangehaving a first and second surface, an aperture disposed within saidflange wherein said aperture further includes walls extending from saidfirst surface of a said flange, said walls forming a bulb protrudingfrom said first surface of said flange, wherein said bulb forms achamber in communication with said aperture and being adapted to receivea tongue.
 8. The device according to claim 7, wherein said flange andsaid bulb are formed of a unitary body.
 9. The device according to claim8, wherein a vacuum is formed in said bulb by compressing said walls andinserting a tongue into said aperture.
 10. The device according to claim9, wherein said walls form a smooth continuous surface with said firstsurface of said flange.
 11. The device according to claim 8, whereinsaid flange is adapted to be received between a person's lips and teeth.12. The device according to claim 8, wherein said device is constructedof one of the materials chosen from the group consisting ofpolyvinylchloride, urethane, polyethylene, and silicon.
 13. A method ofretaining a tongue in a predetermined position, the method comprising:forming a vacuum within a tongue retention device by squeezing the wallsof a protrusion extending from a flange of said tongue retention device;inserting a tongue through an aperture formed in said flange, whereinsaid tongue is received by said protrusion; releasing said walls,thereby forming a vacuum within said protrusion; and positioning saidtongue retention device between a user's lips and teeth.